Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Belimumab, a B-lymphocyte stimulator, was FDA-approved March 2011 for the treatment of adult patients with active, autoantibody-positive SLE receiving standard of care (SOC) medications. Using data from a large, privately-insured US administrative claims database, we sought to identify and characterize a cohort of SLE patients who initiated belimumab treatment.
Methods: A retrospective cohort analysis was conducted in the US Truven Health MarketScan® Commercial Claims and Encounters Database (study ID 204489). Patients were aged 18-64 years at first belimumab infusion (index date) during the study period (2010 – end of available 2014 data). SLE diagnosis was based on ICD-9 code 710.0 documented prior to/on index date. We included patients with complete medical and pharmacy benefits ≥6 months prior to and ≥12 months after the index date. Demographic and clinical characteristics, SOC medication use, healthcare utilization and estimates of SLE disease and flare severity during the 6 month pre-index period were evaluated. Belimumab discontinuation was defined as ≥84 day gap in infusions.
Results: N=762 patients met the inclusion criteria. Mean age at index date was 44 years (SD 11) and 94% were female. Pre-index period diagnosed co-morbidities included musculoskeletal (67%), cardiovascular (41%), central nervous system (39%), mucocutaneous (27%), hematologic (22%) and lupus nephritis (7%) disease. Medications prescribed in the pre-index period included oral corticosteroids (73%), antimalarials (66%), immunosuppressants (60%) and NSAIDs (30%); not mutually exclusive. In the pre-index period, ~80% of patients were prescribed ≥2 SOC medications (excluding NSAIDs), and the mean prednisone-equivalent dosage for the cohort was 7.3 mg/day (SD 13.7); 34% had a mean prednisone-equivalent dose ≥7.5 mg/day. Healthcare utilization in the 6-month pre-index period included ≥1 inpatient visit (12%), emergency department visit (28%) and outpatient procedure (47%) or laboratory test (48%). A disease severity algorithm estimated mild, moderate, and severe disease in the pre-index period for 32%, 55%, and 13% of patients, respectively. Ninety-four percent experienced ≥1 flare in the pre-index period, with the most severe flare classified as mild (17%), moderate (71%) and severe (12%). Mean number of belimumab infusions in the post-index period was 12 (SD 9), with mean 11 months of belimumab use (SD 9). Belimumab was discontinued by 25% of patients during the ≥12-month post-index period, and 60% of patients received belimumab for ≥6 months.
Conclusion: In this large sample of belimumab treatment initiators, there was a high frequency of oral corticosteroid/immunosuppressant use in the 6 months prior to initiating belimumab treatment. Polytherapy was the norm, but ~20% were on either one medication or none. Prior to belimumab treatment, most patients had moderate to severe disease, and nearly all experienced ≥1 flare. More than 50% of patients continued belimumab treatment for ≥6 months. Reasons for discontinuation were not ascertainable in this data source, and future analyses are planned to assess the comparative effectiveness of adding belimumab to SOC treatment.
To cite this abstract in AMA style:Hill D, Kan H, Egger P, Chang DJ, Eudy A, Maskell J, Costenbader KH. Characteristics of Patients Diagnosed with Systemic Lupus Erythematosus (SLE) Initiating Treatment with Belimumab in a US Commercially Insured Database: 2010-2014 [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/characteristics-of-patients-diagnosed-with-systemic-lupus-erythematosus-sle-initiating-treatment-with-belimumab-in-a-us-commercially-insured-database-2010-2014/. Accessed January 28, 2022.
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